Hyperion Therapeutics, Inc. (HPTX) announced that its Marketing Authorisation Application (MAA) for Ravicti has been accepted by the European Medicines Agency (EMA.TO) after the latter completed its technical and content validation. Hyperion is looking to get Ravicti approved for the treatment of urea cycle disorders (UCDs).
Ravicti will now be reviewed by the Rapporteurs and the Committee for Medicinal Products for Human Use. The EU filling of Ravicti was based on positive results from 10 controlled and uncontrolled studies on the product.
Ravicti is already approved in the U.S. as a nitrogen-binding agent for chronic management in adult and pediatric UCD patients of more than two years of age, who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. In May 2013, Ravicti received orphan drug status in the U.S. for this indication.
We remind investors that Hyperion acquired worldwide rights to Ravicti from Ucyclyd Pharma Inc., a subsidiary of Valeant Pharmaceuticals International, Inc. (VRX), for an upfront payment of $6 million. The future payments will be based on the achievement of regulatory milestones in indications other than UCD, sales milestones, and mid-to-high single-digit royalties on global net sales of Ravicti.
Hyperion recorded total sales of $15.5 million from Ravicti. Further market expansion of the drug will drive sales. The majority of Hyperion’s revenues comes from Ravicti sales. As a result, the success of the drug is crucial for the company.
Hyperion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Regeneron Pharmaceuticals, Inc. (REGN) and The Medicines Company (MDCO). Both stocks carry a Zacks Rank #1 (Strong Buy).